1. Incorporation by Reference
Applicant hereby incorporates herein by reference any and all U.S. patents and U.S. patent applications cited or referred to in this application.
2. Field of the Invention
Aspects of this invention relate generally to artificial airway devices, and more particularly to supraglottic airway devices for seating within and/or sealing a patient's airway so as to enable spontaneous or positive-pressure ventilation.
3. Description of Related Art
The following art defines the present state of this field:
U.S. Pat. No. 3,924,636 to Addison is directed to an endotracheal tube holder for holding an endotracheal tube in a patient's mouth during surgery. The tube holder comprises a flexible, adhesive-backed strip adapted to be secured over the mouth of the patient. The strip is provided with a central opening through which the endotracheal tube can be inserted, and a holding strap having releasable, self-adhering ends is mounted on the strip adjacent the opening. When the endotracheal tube is properly positioned, the holding strap is wrapped securely about the tube and fastened to itself to hold the tube in place.
U.S. Pat. No. 3,948,273 to Sanders is directed to an endotracheal or tracheostomy tube having a non-sticking inside surface for allowing for the free movement of a suction catheter through the tube. The non-sticking surface is in the form of a series of grooves separated by ridges having thin edges extending through the length of the tube for engaging the surface of the catheter.
U.S. Pat. No. 4,170,232 to Khoury is directed to a tracheo-bronchial sampler device comprising a tubular member insertable into a chest tube and defining a passage through which a sampling catheter can be passed when the chest tube is inserted into the trachea of a patient, in which means are provided for spacing the passage of said tubular member away from the inner wall of said chest tube, as well as stop means for preventing the insertion of the tubular member through the chest tube beyond a predetermined point. The device enables a sample to be obtained from the desired tracheal region without undesired contamination as the sampling catheter is inserted into the patient.
U.S. Pat. No. 5,033,466 to Weymuller, Jr. is directed to an improved double-cuffed endotracheal tube designed for insertion through the mouth of a patient to provide a passage for artificial respiration. The device includes an elongated flexible tube having proximal and distal end portions, the distal end portion designed for insertion into a patient and the proximal end portion capable of connection to an artificial respirator. The tube includes a lower inflatable-deflatable cuff located above the distal end portion and secured to and encircling the tube. When properly positioned and inflated, the lower cuff sealingly engages the inner wall of the trachea below the larynx and prevents secretions from traveling into the upper trachea or larynx. The tube also includes an upper inflatable-deflatable foam-filled cuff secured to and encircling the tube above the lower cuff. The upper cuff is located on the tube at a predetermined point for positioning in the larynx between the vocal cords and cricoarytenoid joint. When properly positioned, the upper cuff extends equal distances above and below the glottis, and upon expansion or inflation, engages the interior surfaces of the larynx, preventing contact of the tube with those surfaces. The upper foam-filled cuff is designed to provide a sufficiently large area of contact between the cuff and laryngeal tissues to evenly distribute the pressure exerted by the endotracheal tube throughout the cuff, and protects the laryngeal tissues from injuries commonly caused by prolonged intubation of conventional endotracheal tubes.
U.S. Pat. No. 5,918,598 to Belfer et al. is directed to a strapless respiratory facial mask for attachment to the wearer's face including a mask having a central section and three edges forming a generally triangular configuration for covering and surrounding the nose of the wearer; wherein the first and second edges of the mask extend along the opposite sides of the nose of the wearer, and the third edge extends across the upper lip area of the wearer. The central section of the mask is formed of a thermoplastic material and has a first central opening formed therein for making an external connection to the mask, and having a second central opening below the first central opening and an external tubular section connected to the second central opening for making a connection to a gas supply. The mask further includes an elastic and moldable cushioning material connected to the first, second and third edges of the mask to form a peripheral sealing section for engaging the facial contours and skin of the wearer's face. The peripheral sealing section includes first, second and third sealing section edges. In addition, the mask also includes a plurality of sealing strips formed of the cushioning material for attachment to one or more of the first, second or third sealing section edges for providing an increased sealing area for the mask.
U.S. Pat. No. 5,937,861 to Augustine is directed to an endotracheal or tracheostomy tube with a self-inflating cuff near its distal end including one or more resilient, compressible support parts within the cuff for exerting a low sealing pressure against a trachea during expiration.
U.S. Pat. No. 5,988,167 to Kamen is directed to an artificial airway provided for permitting medical personnel access to a patient's airway. The artificial airway includes a foam cuff laryngeal mask having an air tube, a pilot tube, and a laryngeal mask. The air tube and the laryngeal mask cooperate to form a gas passage that permits gases to flow through the foam cuff laryngeal mask. The laryngeal mask includes a foam cuff having a pliable sheath filled with a resilient material. Air is drawn out of the resilient material through the pilot tube which causes the foam cuff to deflate. The foam cuff laryngeal mask is then inserted into the patient's airway and positioned over the larynx. Air is allowed to enter the pilot tube and the resilient material expands so that the foam cuff forms a substantial seal with the larynx.
U.S. Pat. No. 6,012,452 to Pagan is directed to a laryngeal mask airway having a foam cuff formed on the patient surface of a plate attached at the patient end of a tube. The cuff is of a self-skinning foam so that the skin of the foam forms the outer surface of the cuff and seals with the plate. An air lumen extruded along the tube opens at one end into the interior of the cuff and at the other end connects with an air line. The cuff can be compressed for insertion and removal by applying suction to the air line.
U.S. Pat. No. 6,079,409 to Brain is directed to an intubating LMA construction featuring a rigid airway tube wherein curvature in a single plane establishes essentially an arcuate path of angular extent in the preferred range of 130 degrees, plus or minus 5 degrees, which has been found to be in substantial anatomical conformance with the adult human's airway path, between a proximal end of the arc at substantial register with the longitudinal midpoint of the hard palate, and a distal end that faces and is at short offset from the glottic aperture, it being understood that these findings apply to suitably quantified allowance for variations in patient-head anatomy, as is for example customary for different sizes of LMA devices, each of which is adapted to serve one of five selected patient-size ranges. The proximal end of the rigid tube is suitably a short straight portion which is tangentially and integrally related to the proximal end of the arc. And the distal end of the arc is fitted with flexible mask structure of preferably elastomeric material such as silicone rubber, wherein an internal ramp formation within the mask structure assures a limited but important measure of further and stabilized guidance of an ET which has emerged from the distal end of the rigid tube, such that unguided displacement of the ET (i.e., beyond the ramp) is oriented to target safe entry of the ET into the glottic opening.
U.S. Pat. Nos. 6,119,695 and 6,338,343 to Augustine et al. are directed to an airway device for sealing against the laryngeal opening including an air tube with proximal and distal ends and a sealing member attached to the distal end. The sealing member has a distal portion with a pair of opposing lateral flanges for engaging the cricoid cartilage to laterally align the sealing member with respect to the laryngeal inlet. The sealing member has a compressible anterior surface that contacts and seals against the laryngeal inlet. A tubular extension of the distal end of the air tube projects through and beyond the compressible anterior surface. The sealing member has a pronounced sigmoid shape having a lower section which, together with the tubular extension, creates a hook that provides an end point for accurate cephalad-caudad depth placement of the sealing member against the rim of the laryngeal inlet.
U.S. Pat. No. 6,196,223 to Belfer et al. is directed to a strapless respiratory facial mask for attachment to the wearer's face including a moldable laminated gasket member having a cushioning layer and an adhesive layer for engaging the facial contours and skin of the wearer's face; and the gasket member having a central opening for receiving the nose of the wearer. The facial mask further includes a nose piece member having a central section and three edges forming a generally triangular configuration for covering and surrounding the nose of the wearer. The central section of the nose piece member also includes a first opening for connecting to a gas supply; and the nose piece member is adhered along its three edges to the cushioning layer on the gasket member to form a peripheral seal. The central section of the nose piece member has a contoured shape for receiving the wearer's nose therein.
U.S. Pat. No. 6,318,367 to Mongeon is directed to an artificial airway device (also known as a Laryngeal Mask Assembly, “LMA,” or Disposable Laryngeal Mask Assembly, “DLMA”) used to facilitate lung ventilation in an unconscious patient and methods for using an artificial airway device. The device includes a curved but flexible airway tube and a hollow mask support at one end of the airway tube. The mask support includes a fairly rigid support base and a flexible, generally annular peripheral skirt which is attached to the support base. A distal tip of the mask support is narrowed and projects outwardly, thereby providing a nose portion which is used to easily locate the distal tip of the mask in the entrance into the esophagus. The skirt is capable of conforming to the space behind the larynx so as to form a seal around the circumference of the laryngeal inlet without penetrating into the interior of the larynx. The skirt surrounds a hollow interior space or lumen of the mask base into which the airway tube opens. During insertion of the LMA into the patient, the skirt is contracted, to make the LMA easier to insert into the patient's airway. The skirt of the mask can be selectively manipulated, e.g. expanded, to improve the sealing contact with the tissues around the circumference of the laryngeal inlet. The skirt, when expanded, and the support base form a “cup-like” shape, which enhances the stabilization and sealing of the mask in the airway.
U.S. Pat. No. 6,390,093 to Mongeon is directed to an artificial airway device used to facilitate lung ventilation in an unconscious patient, and methods for using and inserting an artificial airway device. The device includes a curved but flexible airway tube and a mask portion. A mask opening portion is shaped so as to fit closely adjacent and closely over the patient's laryngeal opening. A seating tip includes a series of thin, flexible fins or gills which project from a finger portion extending from the mask opening portion. The fins or gills seat against the pharyngeal side of the cricoid, just above the esophagus. The mask portion can be anchored against a relatively hard surface without causing damage to delicate tissue in the esophagus. The seating tip provides a reference for the person inserting the artificial airway device which ensures that the mask portion is properly in place and adequately anchored. The artificial airway also includes an inflatable cuff used to anchor the artificial airway in place.
U.S. Pat. Nos. 6,427,686 and 6,830,049 to Augustine et al. are directed to a laryngeal airway device for sealing against the laryngeal opening including an air tube with proximal and distal ends and a sealing member attached to the distal end. The sealing member includes a coupler for coupling the device to an introducer. Complementing the laryngeal airway device is an introducer that includes a track for receiving the coupler of the laryngeal airway device and guiding the sealing member to a sealing position with respect to the laryngeal inlet. The introducer may include an epiglottic engager on a distal end to engage the epiglottis and retain it while the sealing member is being tracked to engagement with the laryngeal inlet.
U.S. Pat. No. 6,604,525 to Pagan is directed to the mask of a laryngeal mask assembly having a mount and an integral cuff at the patient end of a tube. The mount is of a thermoplastic material and the cuff is made by blow moulding from the material of the mount. A separate retaining plate seals an edge of the cuff with the mount and traps an inflation tube extending from the cuff to the inflation line of the tube.
U.S. Pat. No. 6,729,325 to Alfery is directed to an oral airway (510) including an elongate tubular member (512) having a distal (510) and a proximal end (514), the oral airway being configured to place the distal end in a supraglottic position when operatively placed within the hypopharynx of a patient. A temperature sensor (554) is operatively associated with the elongate tubular member to detect a core temperature of a patient with the distal end of the oral airway operatively placed in a superglottic position within the hypopharynx of the patient.
U.S. Pat. No. 6,745,773 to Gobel is directed to a tracheal tube by which the trachea is closed watertight by a fixation cuff blocking the trachea below the glottis, through which a ventilation cannula passes, and, situated cranially to it, above the cuff, a tampon-bladder made of flexible material expansible through the influx of fluid, which when filled differs in shape from the shape of the cuff, representing an improvement by means of which a patient could be intubated in the gentlest way over a long period with minimal risk of infection. In the invention this is accomplished by situating the tampon-bladder immediately against the cuff and constructing it of foil-like material and so designing it that when fully distended in size it fills the subglottal space.
U.S. patent application Ser. No. 10/985,935 to Koyama et al. is directed to an oral airway, which is used by being inserted into the mouth of a patient who is suffering from unconsciousness or has lost consciousness to secure an airway of the patient, adapted to be used with a tube to be inserted into the trachea of the patient through the mouth thereof. The oral air way includes a main body, and an insertion part provided on the main body. The insertion part is adapted to be inserted into the trachea of the patient through the mouth thereof so that an appropriate portion of the insertion part at the side of the distal end thereof comes into contact with the root of the tongue of the patient to secure the airway of the patient. The insertion part includes a guide groove for guiding the tube when the tube is inserted into the trachea of the patient, and the guide groove has a structure from which the tube can be separated after the distal end of the tube has been inserted into the trachea of the patient.
The prior art described above teaches an endotracheal tube holder, an endotracheal tube having a non-sticking inner surface, a tracheo-bronchial sampler device, a double-cuffed endotracheal tube, a strapless respiratory facial mask for customizing to the wearer's face, a tracheal tube with self-supporting tracheal tube cuff, a foam cuff for a laryngeal mask airway, laryngeal mask assemblies, an intubating laryngeal mask, an airway device with provision for lateral alignment, depth positioning, and retention in an airway, an artificial airway device and method of its use, an airway device with provision for coupling to an introducer, laryngeal mask airways and their manufacture, a perilaryngeal oral airway, a tracheal tube, and an oral airway and airway management assistive device provided with the oral airway, but does not teach a supraglottic airway device having a slidable face plate for sealing around the mouth, a reinforced foam tip for insertion within the hypopharynx or cricopharynx, or an expanding foam cuff for seating and sealing within the oropharynx or nasopharynx. Aspects of the present invention fulfill these needs and provide further related advantages as described in the following summary.